Unified Drug Mixer And Dispenser

ABSTRACT

A unified dispenser for holding, mixing, and dispensing a drug includes a housing holding a diluent reservoir, a drug reservoir, and a tubing set connecting and defining a fluid communication path therebetween. A first occlusion is at the diluent reservoir, and a second occlusion is at the drug reservoir. In a storage state of the dispenser, the first and second occlusions are entirely encased within the housing and occlude the fluid communication path. First and second pull assemblies extend outside the housing. The first and second pull assemblies are coupled to the first and second occlusions, respectively, so that removal of the first and second pull assemblies removes the first and second occlusions and joins the diluent reservoir to the drug reservoir in fluid communication through the tubing set, thereby arranging the dispenser from the storage state to a use state.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims the benefit of U.S.patent application Ser. No. 15/687,393, filed Aug. 25, 2017, which is acontinuation of and claims the benefit of prior U.S. patent applicationSer. No. 15/041,157, filed Feb. 11, 2016, all of which are herebyincorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical equipment, and moreparticularly to devices for mixing and dispensing drugs to a patient.

BACKGROUND OF THE INVENTION

Precise infusion of large volumes of liquid medicament through anadministration line is usually accomplished by an infusion pump.Traditional infusion pumps make use of a flexible infusion bag suspendedabove the patient. For many medicaments and drugs, a pharmacist, nurse,doctor, or other medical professional is required to prepare theinfusion bag by reconstituting, diluting, or mixing the medicament ordrug in preparation for its delivery and use with a pump. Such methodsare cumbersome, imprecise, require many time-consuming steps by medicalprofessionals, are susceptible to medication errors, and require bedconfinement of the patient. Mixing and administration of solid statedrugs—whether lyophilized powders, crystalline structures, or some othersolid state—and solution state drugs is time consuming and involves alarge number of complicated steps.

Other problems exist with conventional pumps. Periodic monitoring of theapparatus by a nurse, doctor, or other medical professional is requiredto detect malfunctions of the infusion pump. Accordingly, over theyears, infusion pumps developed into increasingly more complex devicesof great expense and sophistication. Such devices include a large numberof features, options, and programmability possibilities. While thosecapabilities can be advantageous in providing a range of customizationto medicament administration, they also lead to use error, and thepossibility of patient harm, injury, or death.

Complicated infusion pumps also typically require many time-consumingsteps for setup, including applying both the medicament reservoir andthe administration line to the pump. Increased preparation requirementsincrease the risk of contaminating the pump, the medicament reservoir,the administration line, or other elements of the intravenous linesystem, posing a hazard to the patient. With mixed drug administrationsystems (such as reconstituted or diluted drug administration systems),there is also an increased risk that the drug or diluent into which thedrug is diluted will be contaminated, mis-measured, or otherwiseincorrectly prepared, leading to patient harm. An improved system forproviding a convenient, reliable, accurate, and sterile infusion oflarge volumes of mixed drugs is needed.

SUMMARY OF THE INVENTION

A unified drug mixer and dispenser is described herein. The dispenserholds, mixes, and dispenses a drug to a patient with a dramaticallylower risk of contamination or improper operation, thereby providing amore reliable, consistent, and safe patient experience. The dispenser isunified in that all components are encased and sterile—eitheraseptically or through a sterilization process—and do not require theassembly, preparation, and set up conventionally required by prior artdispensers that can lead to patient harm. Rather, the dispenser includesa housing holding a diluent reservoir, a drug reservoir, and a tubingset connecting the two reservoirs and defining a sterile fluidcommunication path together with them. Occlusions occlude this sterilepathway: a first occlusion is located at the diluent reservoir, and asecond occlusion is located at the drug reservoir. The occlusions areencased entirely within the housing, but pull assemblies, which extendfrom the occlusions to outside the housing, provide the medicalprofessional with a way to remove those occlusions without invading thesterile communication path. By removing the pull assemblies, a medicalprofessional both opens the fluid communication path so that fluid mayflow through it, and energizes the device for operation.

BRIEF DESCRIPTION OF THE DRAWINGS

Referring to the drawings:

FIGS. 1 and 2 are front and rear perspective views illustrating thehousing of a unified drug mixer and dispenser;

FIG. 3 is a section view of the unified drug mixer and dispenser of FIG.1 taken along the line 3-3 in FIG. 1;

FIG. 4 is an enlarged section view taken along the line 4-4 in FIG. 1,showing in detail a tubing set and pump assembly of the unified drugmixer and dispenser of FIG. 1;

FIG. 5 is an isolated, exploded view of the pump assembly and portionsof the tubing set;

FIG. 6 is a section view of the unified drug mixer and dispenser of FIG.1 taken along the line 6-6 in FIG. 1; and

FIG. 7 is a rear perspective view of the unified drug mixer anddispenser of FIG. 1, with the housing hidden and the pump assemblypartially exploded.

DETAILED DESCRIPTION

Reference now is made to the drawings, in which the same referencecharacters are used throughout the different figures to designate thesame elements. FIGS. 1 and 2 illustrate front and rear perspective viewsof a unified drug mixer and dispenser 10 useful for holding, mixing, anddelivering a large quantity of medicament to a patient via anadministration line at a controlled rate set according to severalparameters. The dispenser 10 includes a housing 11 containing a diluentreservoir 12 and a drug reservoir 13. The dispenser 10 is a“ready-to-use” dispenser 10 in that it uniquely contains both a drug anda diluent, in disparate sterile reservoirs within a single unit, andthat it mixes and dispenses the drug to a patient through sterilepathways without the need for separate mixing or preparation which couldexpose the drug or the components of the dispenser to contamination. Thedrug in the drug reservoir 13 is in a concentrated form, either in asolid state or solution state. For example, solid state drugs includepowdered, lyophilized powdered, crystallized, dried, and other solidstate forms. Drugs in a solution state are emulsions, aqueous solutions,or other liquid preparations wherein the drug is dissolved, dispersed,suspended, or otherwise carried in a solvent or liquid. Because thediluent reservoir 12 and the drug reservoir 13 contain and hold the drugseparately from the diluent, and because, as will be explained, thedispenser 10 reconstitutes, mixes, or dilutes the drug by communicatingdiluent into the drug reservoir, the structure and function of thedispenser 10 does not change depending on whether the drug reservoircontains a solid state or solution state drug. As such, one havingordinary skill in the art will understand that the following descriptionapplies equally to a dispenser 10 for holding, reconstituting, anddispensing a solid state drug as it does for holding, diluting, anddispensing a solution state drug. Therefore, throughout thisdescription, the word “reconstitute,” and variations thereof, is usedprimarily when referring to solid state drugs, and the words “mix” and“dilute,” and variations thereof, are used primarily when referring tosolution state drugs, but all three of the terms may also be used alonewhen referring to both solid state and solution state drugs, withoutexclusion of one or the other. Indeed, the term “mix” will be used mostgenerally and is meant to include “reconstitute” and “dilute.”

The diluent reservoir 12 and drug reservoir 13 are both coupled to eachother and to a pump to mix the diluent and the drug in a solid orsolution state into a mixture, and to then communicate that mixturethrough an administration line 14 to a capped coupling 15. This coupling15 then conventionally interfaces with an intravenous line forapplication to a patient. The dispenser 10 is preferably a unified,single-use, disposable dispenser with a sterile, pre-filled diluent, asterile, prefilled drug, and which is ready for use without the need fordisassociated preparation, assembly, or complicated programming. Thedispenser 10 thus helps prevent user error, infection, injury, and evendeath.

The housing 11 is generally rectangular prismatic and constructed from adurable, rigid plastic, either in a monolithic construction or formedfrom several pieces coupled together by snap tab fittings, adhesive,sonic welding, screws, or like fastening methods suitable for anassembled enclosure. The embodiment shown throughout these drawings is apreferred, yet not limiting embodiment, and it should be understood thatvariations in the design of various structural elements—such as thehousing 11—do not alter the principle operation of the dispenser 10. Thediluent reservoir 12, described in detail below, is seated into thehousing 11 and is preferably a flexible, collapsible container or bagincluding a semi-rigid perimeter edge 20 to provide the reservoir 12with some degree of rigidity. A hole 21 is formed through the top of theedge 20 so that the dispenser 10 can be hung from a stand. For purposesof clarity of the description, the terms “vertical” and “horizontal”will be used herein to describe various structures and orientations ofstructures. “Vertical” is used herein to indicate an orientationgenerally parallel to a line running from the top of FIG. 1 to thebottom of FIG. 1, and “horizontal” is used herein to indicate anorientation generally perpendicular to vertical. The hole 21 allows thedispenser 10 to hang in a vertical orientation. For this reason, and forpurposes of orientation, the relative location of structural elementsand features may be described in terms of “above” or “upward” and“below” or “downward.”

Referring still to FIGS. 1 and 2, the housing 11 has a thin-wallconstruction and includes a front 22, back 23, top 24, and bottom 25.The housing 11 includes opposed sides 26 and 27, which are referred toherein as a left side 26 and a right side 27. A window 30 is formed inthe front 22 of the housing 11 and an opposed window 31 is formed in theback 23 of the housing 11. The windows 30 and 31 correspond to eachother in size and shape, are oval-shaped, and frame the drug reservoir13 proximate to the top 24 and the right side 27 of the housing 11. Thewindows 30 and 31 are preferably, though not necessarily, each open,having no covering, film, or other barrier disposed thereacross. Each ofthe windows 30 and 31 has parallel sides and a curved top and curvedbottom. The windows 30 and 31 provide a person with the unique abilityto view and observe the drug in the drug reservoir 13. The opposedwindows 30 and 31 also uniquely allows the drug reservoir 13 to bebacklit with any of a variety of illumination techniques for visual andother analysis.

The front 22 of the housing 10 has a wide, flat face 32 into which isset a plurality of control buttons and a display 33. On the face 32,proximate to the left side 26, a setting button 34 and two navigationbuttons 35 and 36 are set into and extend through the housing 11. Thebuttons 34, 35, and 36 are carried on and operatively coupled to aprinted circuit board 40 (hereinafter, “PCB 40”) within the housing 11,as shown in FIG. 6. The display 33 is also carried on the PCB 40 and setinto and through the face 32, in a window in the housing 11 sized andshaped to exactly correspond to the display 32. Depressing the settingand navigation buttons 34, 35, and 36 controls operation of thedispenser, as is described later. Proximate to the right side 27, a mixbutton 41 and a dispense button 42 are set into and extend through thehousing 11. The mix and dispense buttons 41 and 42 are also carried onand operatively coupled to the PCB 40. The setting and navigationbuttons 34, 35, and 36 are aligned vertically with each other, and theopposed mix and dispense buttons 41 and 42 are aligned vertically witheach other. The display 33 is roughly centered between the two sets ofbuttons, and between the sides 26 and 27.

Two pull assemblies 50 and 51, or more simply, pulls 50 and 51, in thedispenser 10 maintain sterility throughout the dispenser 10 and controlactivation and energization of the dispenser 10. Turning to FIG. 1 only,a side pull 50 extends through a narrow slit 52 formed through the leftside 26 of the housing 11. The side pull 50 is a two-ply ribbonconsisting of a wide upper ribbon 53 and a coextensive wide lower ribbon54. The ribbons 53 and 54 are mechanically and electrically coupled toarrange and configure the dispenser 10 from a storage state to anoperation or use state, as is explained in detail later. The ribbons 53and 54 each have anchored ends within the housing 11, as seen in FIG. 3,and as is explained below. The ribbons 53 and 54 are preferably securedto each other, such as at their free ends, which extend out of thehousing 11 so that the ribbons 53 and 54 of the pull 50 are grasped andpulled simultaneously. Now turning to FIG. 2, a rear pull 51 is shown asextending through a narrow slit 55 in the back 23 of the housing 11. Therear pull 51 is also a two-ply ribbon having a wide upper ribbon 56 anda coextensive wide lower ribbon 57, which are mechanically andelectrically coupled to arrange and configure the dispenser 10 from thestorage state to the use state. The ribbons 56 and 57 each have anchoredends within the housing 11, as seen in FIG. 3. The ribbons 56 and 57 arepreferably secured to each other, such as at their free ends, whichextend out of the housing 11 so that the ribbons 56 and 57 of the pull51 are grasped and pulled simultaneously.

Turning now to FIG. 3, which is a section view taken along the line 3-3in FIG. 1, an interior 60 of the dispenser 10 is shown along with thevarious components encased within the housing 11. The interior 60 is asingle compartment defined between the front 22, back 23, top 24, bottom25, and opposed sides 26 and 27. As can be seen most clearly in FIG. 3,the top 24 of the housing 11 itself includes an open mouth 61, intowhich the diluent reservoir 12 is seated. The diluent reservoir 12 isseated continuously against the open mouth 61. While the seal formed bythis seating does not need to maintain sterility of the interior 60, itdoes provide a seal against intrusion of dust and debris, and thusprotects the various structural elements and features carried within theinterior 60 from damage.

A sterile fluid communication path 62 is carried by the dispenser 10 todeliver a drug to a patient. The fluid communication path 62 uniquelyprovides a sterilized, assembled, transported, stored, connected, andset up system for delivering the drug to a patient safely and withoutcompromising sterility. The fluid communication path 62 includes thediluent reservoir 12, the drug reservoir 13, a diluent aseptic connectorassembly 63 (hereinafter, the “DACA 63”), a drug aseptic connectorassembly (hereinafter, the “LACA 64”), a tubing set 65, and theadministration line 14. The fluid communication path 62 is a sterilepathway for delivering the reconstituted, mixed, or diluted drug to apatient and maintains a sterile pathway during the lifecycle of thedispenser 10. The internal surfaces of each of the components of thefluid communication path 62, namely, the diluent reservoir 12, the drugreservoir 13, the DACA 63, the LACA 64, the tubing set 65, and theadministration line 14 are sterilized prior to assembly, and thedispenser 10 is assembled carefully to maintain the sterility of thefluid communication path 62, so that the dispenser 10 reliably providesa safe drug to the patient. Preferably, and as described in more detailbelow, the diluent reservoir 12 together with a portion of the DACA 63,is sterilized separately from the drug reservoir 13 together with aportion of the LACA 64, which is sterilized separately from the tubingset 65 and administration line 14 and complemental portions of thediluent and drug aseptic connectors 63 and 64. The fluid communicationpath 62 is then assembled into the housing 11 with the other structuralelements and features carried by the housing 11 which interact with thefluid communication path 62 to store, power, operate, and control thedispenser 10.

The diluent reservoir 12 has been discussed briefly above. Withreference still to FIG. 3, the diluent reservoir 12 extends entirelybetween the left and right sides 26 and 27. The diluent reservoir 12 isgenerally rectangular prismatic in shape but for a notched corner 70.The corner 70—an inside corner—is notched inwardly into the diluentreservoir 12 to form a recess into which the drug reservoir 13 isdisposed when applied to the housing 11, accommodating the drugreservoir 13 against the housing 11. The diluent reservoir 12 is apre-filled, flexible, collapsible container or bag. “Pre-filled” is usedhere to mean that the diluent fluid is applied to the diluent reservoir12 before assembly of the diluent reservoir 12 into the housing 11 andbefore the diluent reservoir 12 is coupled to any other structuralelement or feature of the dispenser 10. Further, the diluent reservoir12, together with a portion of the DACA 63, is sterilized beforeassembly into the housing 11 and before coupling to the other structuralelements and features of the dispenser 10. The diluent reservoir 12 istransparent or at least translucent so that a user can observe thediluent therein and the mixing of the drug in the diluent reservoir 12.In some embodiments, the diluent reservoir 12 is contained within atransparent, rigid encasing surrounding the diluent reservoir 12 andproviding means, similar to the rigid edge 20 and the hole 21 formedtherein, for hanging the dispenser 10 from a stand. In some embodiments,the diluent reservoir 12 includes graduated volume indication lines toindicate the volume of liquid in the diluent reservoir 12. The diluentreservoir 12 preferably can hold between approximately 50 and 500milliliters of diluent. The type of diluent itself will be determined ona case-by-case for each patient by prescription, but will typically beeither Water-for-Injection, 5% dextrose, 0.9% sodium chloride, LactatedRinger's Injection, Normosol®-M, ISOLYTE® E, or a combination of thesecompounds. The diluent is not shown in the drawings, as one havingordinary skill in the art will readily appreciate its existence and flowthrough the dispenser 10. The diluent reservoir 12 is fluid impermeable,constructed from a material or combination of materials havingcharacteristics of inertness, low permeability, durability, flexibility,and collapsibility, such as PVC, polypropylene, HDPE, COC, or COP. Thediluent reservoir 12 includes a spout 71 terminating in an upper diluentaseptic connector 72 (hereinafter, “UDAC 72”) which is mated against alower diluent aseptic connector 73 (hereinafter, “LDAC 73”) to form theDACA 63. The spout 71 is preferably sonically welded to the UDAC 72 topermanently couple those components.

The DACA 63 is shown in greater detail in FIG. 4. The UDAC 72 and LDAC73 are mated to each other in compression to form a single, leak-proofassembly. The UDAC 72 includes a short post 74 and a wide, circular base75 depending coaxially therefrom. A single open throat 80 in the spout71 of the diluent reservoir 12 transitions into and thus communicateswith both a major bore 81 and a minor bore 82 extending through the post74 and the base 75. The minor bore 82 has a diameter approximatelyone-third the diameter of the major bore 81. Both of the major and minorbores 81 and 82 provide a pathway for movement of fluid through the UDAC72, so that fluid flows both into and out of both of the major and minorbores 81 and 82 depending on the selected mix or dispense function ofthe dispenser 10.

Two cylindrical seats are formed into a face 85 of the base 75 oppositethe post 74: a major seat 83 coaxial to and communicating with the majorbore 81, and a minor seat 84 coaxial to and communicating with the minorbore 82. A single gasket 86 is fit into both of the major and minorseats 83 and 84. The gasket 86 has a figure-eight shape with a largeannulus and a small annulus and two holes, formed coaxially though thelarge and small annuli. The gasket 86 has a height just slightly greaterthan the depth of the major and minor seats 84 and 85, so that thegasket 86 protrudes slightly beyond the face 85 of the base 75. Thegasket 86 is constructed from a material or combination of materialshaving characteristics of inertness, low permeability, durability, andcompressibility, such as rubber. The upper ribbon 53 is applied over thegasket 86, is adhered to the face 85 of the UDAC 72 with a peelablebond, and is thereby sealed to the face 85 of the UDAC 72. The upperribbon 53 completely overlies the gasket 86 with a continuous, annularseal formed between the upper ribbon 53 and the face 85 to act as abarrier to fluid migration.

The LDAC 73 is somewhat similar to the UDAC 72, though deserves its owndescription for explanation of its differences. The LDAC 73 includes apost 90 and a wide, circular base 91 extending coaxially therefrom. Amajor bore 92 extends vertically through the base 90 and turnslaterally, reducing in diameter in the post 91 before extendinghorizontally out of the post 91 as a barbed coupling 94. A minor bore 93extends vertically through both the base 90 and the post 91 andterminates as a barbed coupling 95 pointing down. The major and minorbores 92 and 93 are entirely separated by an internal wall in the post90 and the base 91. The minor bore 93 has a diameter approximatelyone-third the diameter of the major bore 92; the major bore 92corresponds in size and shape to the major bore 81 of the UDAC 72, andthe minor bore 93 corresponds in size and shape to the minor bore 82 ofthe UDAC 72. Both of the major and minor bores 92 and 93 provide apathway for movement of fluid into and out of the UDAC 72, depending onthe selected mix or dispense function of the dispenser 10.

Two cylindrical seats are formed into a face 98 of the base 91 oppositethe post 90: a major seat 96 coaxial to and communicating with the majorbore 92, and a minor seat 97 coaxial to and communicating with the minorbore 93. A single gasket 99 is fit into both of the major and minorseats 96 and 97. The gasket 99 has a figure-eight shape with a largeannulus and a small annulus and two holes, formed coaxially though thelarge and small annuli. The gasket 99 has a height just slightly greaterthan the depth of the major and minor seats 96 and 97, so that thegasket 99 protrudes slightly beyond the face 98 of the base 91. Thegasket 99 is constructed from a material or combination of materialshaving characteristics of inertness, low permeability, durability, andcompressibility, such as rubber. The lower ribbon 54 is applied over thegasket 99, is adhered to the face 98 of the LDAC 73 with a peelablebond, and is thereby sealed to the face 98 of the LDAC 73. The lowerribbon 54 completely overlies the gasket 99 with a continuous, annularseal formed between the lower ribbon 54 and the face 98 to act as abarrier to fluid migration.

The UDAC 72 and LDAC 73 form a sterile connector, identified as the DACA63, between the diluent reservoir 12 and the tubing set 65. The UDAC 72allows the diluent reservoir 12 to be sterilized separately from thetubing set 65 and then mated to the LDAC 73 without affecting thesterility of either the UDAC 72 or the LDAC 73. To form the DACA 62, theUDAC and LDAC 72 and 73 are aligned with each other so that the majorbores 81 and 92 are aligned and the minor bores 82 and 93 are aligned,and the UDAC and LDAC 72 and 73 are compressed into each other. Fourfingers 100, shown most clearly in FIG. 3, project axially from the base91 of the LDAC 73, each terminating in an enlarged, radiallyinwardly-directed head. The fingers 100 couple and hold the UDAC 72 andLDAC 73 together in mating engagement and coaxial alignment. The fingers100 are circumferentially spaced apart around the UDAC 72 and the LDAC73, further maintaining coaxial alignment between the UDAC 72 and LDAC73. When the UDAC 72 and the LDAC 73 are mated, the fingers 100 fit overthe base 75 of the UDAC 72 and compress the UDAC 72 and LDAC 73together. The gaskets 86 and 99 are thus also aligned and compressedtoward each other, thereby defining a continuous figure-eight shaped padof contact therebetween and sealing the UDAC 72 and the LDAC 73 to eachother for leak-proof fluid communication. Between the gaskets 86 and 99are the upper and lower ribbons 53 and 54. Because the upper and lowerribbons 53 and 54 are so thin, the drawings do not clearly show both ofthe structures; however, one having skill in the art will readilyappreciate and understand that the upper and lower ribbons 53 and 54 areapplied such that they are against each other and between the gaskets 86and 99, respectively, thereby sealing the UDAC 72 and the LDAC 73 andallowing that seal to be removed. The upper and lower ribbons 53 and 54extend from the DACA 63 through the interior 60 and out the left side26. The upper and lower ribbons 53 and 54 are anchored in the DACA 63and define occlusions of the DACA 63 at this anchor. The pull assembly50, which includes the upper and lower ribbons 53 and 54, is suitablefor being easily grasped and pulled such as by the fingers. FIG. 4illustrates the pull assembly 50 still applied to the housing, with theupper and lower ribbons 53 and 54 still within the UDAC 72, and thusFIG. 4 shows the dispenser 10 in a storage state in which fluid may notyet flow into or out of the diluent reservoir 12. Placing the dispenser10 into the use state requires at least removing the upper and lowerribbons 53 and 54 to join the UDAC 72 and the LDAC 73 in fluidcommunication. Arranging the dispenser 10 from the storage state to theuse state is described in further detail above, after a discussion ofthe LACA 64.

Returning to FIG. 3, the drug reservoir 13 is shown nestled into therecess formed between the corner 70 of the diluent reservoir 12 and thehousing 11, proximate to the right side 27. The drug reservoir 13 isgenerally cylindrical and is preferably a glass vial, though in otherembodiments is a plastic vial and a plastic syringe. The drug reservoir13 is open-ended, but closed with an upper drug aseptic connector 110(hereinafter, “ULAC 110”), which is the upper portion of the LACA 64 andis aseptically coupled to a lower drug aseptic connector 111(hereinafter “LLAC 111”). The ULAC 110 allows the drug reservoir 13 tobe pre-filled and sterilized before assembly into the housing 11 andbefore coupling to the other structural elements and features of thedispenser 10. The drug reservoir 13 is preferably transparent or atleast translucent so that a user can observe the drug therein androughly measure the progress of the mixing of the drug as diluent isapplied to and through the drug reservoir 13. In some embodiments, thedrug reservoir 13 includes volume indication lines to indicate thevolume of solid or solution—as the case may be depending on the state ofthe drug—in the drug reservoir 13. The drug reservoir 13 preferably canhold between approximately 0.1 and 2 grams of a drug. The specific drugcarried in the drug reservoir 13 will depend on a case-by-case basis byprescription, but may include, for example, vancomycin. The drug is notshown in the drawing, as one having ordinary skill in the art willreadily appreciate its existence and flow through the dispenser 10during mixing and dispensing.

The drug reservoir 13 is capped with the ULAC 110, which, as seen inFIG. 3 and FIG. 4, includes an enlarged, inwardly-turned annular lipthat catches on, fits over, and secures a neck of the drug reservoir 13.The LACA 64 is shown in best detail in FIG. 4. The ULAC 110 and LLAC 111are mated to each other in compression to form a single, leakproofassembly. The ULAC 110 includes a stem 112 and a coaxial, wider,circular base 113 monolithically formed thereto. The stem 112 extendsupward from the base 113 and is sized and shaped to fit snugly into theneck of the drug reservoir 13. The neck of the drug reservoir 13 ispressed fully into the ULAC 110 until the neck makes contact with thebase 113, thereby forming a seal with the ULAC 110. The inwardly-turnedannular lip of the ULAC 110 is outside the neck of the drug reservoir13, so that the neck of the drug reservoir 13 is disposed between thelip and the stem 112. A major bore 114 and minor bore 115 extend throughentirely the stem 112 and the base 113 and are coupled in fluidcommunication with the interior of the drug reservoir 13. The minor bore115 has a diameter approximately one-third the diameter of the majorbore 114. Both of the major and minor bores 114 and 115 provide apathway for movement of fluid through the ULAC 110, such that fluidflows both into and out of both of the major and minor bores 114 and 115depending on the selected mix or dispense function of the dispenser 10at the time.

Two cylindrical seats are formed into a face 118 of the base 113opposite the stem 112: a major seat 116 coaxial to and communicatingwith the major bore 114, and a minor seat 117 coaxial to andcommunicating with the minor bore 115. A single gasket 120 is fit intoboth of the major and minor seats 116 and 117; the gasket 120 has afigure-eight shape with a large annulus and a small annulus and twoholes formed coaxially though the large and small annuli. The gasket 120has a height just slightly greater than the depth of the major and minorbores 114 and 115, so that the gasket 120 protrudes slightly beyond theface 118 of the base 113. The gasket 120 is constructed from a materialor combination of materials having characteristics of inertness, lowpermeability, durability, and compressibility, such as rubber. The upperribbon 56 is applied over the gasket 120, is adhered to the face 118 ofthe ULAC 110 with a peelable bond, and is thereby sealed to the face 118of the ULAC 110. The upper ribbon 56 completely overlies the gasket 120with a continuous, annular seal formed between the upper ribbon 56 andthe face 118 to act as a barrier to fluid migration.

The LLAC 110 is similar to the LDAC 72 in the LACA 63. The LLAC 110includes a post 121 and a wide, circular base 122 extending coaxiallytherefrom. A major bore 123 extends vertically through the base 121 andturns laterally, reducing in diameter in the post 122 before extendinghorizontally out of the post 122 as a barbed coupling 125. A minor bore124 extends vertically through both the base 121 and the post 122 andterminates as a barbed coupling 126 pointing down. The major and minorbores 123 and 124 are entirely separated by an internal wall in the post121 and the base 122. The minor bore 124 has a diameter approximatelyone-third the diameter of the major bore 123; the major bore 123corresponds in size and shape to the major bore 114 of the ULAC 110, andthe minor bore 124 corresponds in size and shape to the minor bore 115of the ULAC 110. Both of the major and minor bores 123 and 124 provide apathway for movement of fluid into and out of the ULAC 110, depending onthe selected mix or dispense function of the dispenser 10.

Two cylindrical seats are formed into a face 129 of the base 122opposite the post 121: a major seat 127 coaxial to and communicatingwith the major bore 123, and a minor seat 128 coaxial to andcommunicating with the minor bore 124. A single gasket 130 is fit intoboth of the major and minor seats 127 and 128. The gasket 130 has afigure-eight shape with a large annulus and a small annulus and twoholes, formed coaxially though the large and small annuli. The gasket130 has a height just slightly greater than the depth of the major andminor seats 127 and 128, so that the gasket 130 protrudes slightlybeyond the face 129 of the base 122. The gasket 130 is constructed froma material or combination of materials having characteristics ofinertness, low permeability, durability, and compressibility, such asrubber. The lower ribbon 57 is applied over the gasket 130, is adheredto the face 129 of the LLAC 111 with a peeable bond, and is therebysealed to the face 129 of the LLAC 111. The lower ribbon 57 completelyoverlies the gasket 130 with a continuous, annular seal formed betweenthe lower ribbon 57 and the face 129 to act as a barrier to fluidmigration.

The ULAC 110 and LLAC 111 form a sterile connector, identified as theLACA 64, between the drug reservoir 13 and the tubing set 65. The ULAC110 allows the drug reservoir 13 to be sterilized separately from thetubing set 65 and then mated to the LLAC 111 without affecting thesterility of either the ULAC 110 or the LLAC 111. To form the LACA 64,the ULAC and LLAC 110 and 111 are aligned with each other so that themajor bores 114 and 123 are aligned and the minor bores 115 and 124 arealigned, and the ULAC and LLAC 110 and 111 are compressed into eachother. Four fingers 101, shown most clearly in FIG. 3, project axiallyfrom the base 122 of the LLAC 111, each terminating in an enlarged,radially inwardly-directed head. The fingers 101 couple and hold theULAC 110 and LLAC 111 together in mating engagement and coaxialalignment. The fingers 101 are circumferentially spaced apart around theULAC 110 and the LLAC 111, further maintaining coaxial alignment betweenthe ULAC 110 and the LLAC 111. When the ULAC 110 and the LLAC 111 aremated, the fingers 101 fit over the base 113 of the ULAC 110 andcompress the ULAC 110 and LLAC 111 together. The gaskets 120 and 130 arealigned and compressed toward each other, thereby defining a continuousfigure-eight shaped pad of contact therebetween and sealing the ULAC 110and the LLAC 111 to each other for leak-proof fluid communication.Between the gaskets 86 and 130 are the upper and lower ribbons 56 and57. Because the upper and lower ribbons 56 and 57 are so thin, thedrawings do not clearly show both of the structures; however, one havingskill in the art will readily appreciate and understand that the upperand lower ribbons 56 and 57 are applied against each other and betweenthe gaskets 120 and 130, respectively, thereby sealing the ULAC 110 andthe LLAC 111 and allowing that seal to be removed. The upper and lowerribbons 56 and 57 extend from the LACA 64 through the interior 60 andout the back 23. The upper and lower ribbons 56 and 57 are anchored inthe LACA 64 and define occlusions of the LACA 64 at this anchor. Thepull assembly 51, which includes the upper and lower ribbons 56 and 57,is suitable for being easily grasped and pulled such as by the fingers.FIG. 4 illustrates the pull assembly 51 still applied to the housing 11,with the upper and lower ribbons 56 and 57 still within the ULAC 110,and thus FIG. 4 shows the dispenser 10 in a storage state in which fluidmay not yet flow into or out of the drug reservoir 13 to mix with ordispense the drug. Placing the dispenser 10 into the use state requiresat least removing the upper and lower ribbons 56 and 57 from LACA 64 tojoin the ULAC 110 and the LLAC 111 in fluid communication, and, asdiscussed above, also requires removing the upper and lower ribbons 53and 54 from DACA 63 to join the UDAC 72 and the LDAC 73 in fluidcommunication.

Still referring to FIG. 4, energy storage means, or a battery supply131, is also carried in the interior 60 of the housing 11 to power thedispenser 10. The battery supply 131 is preferably located proximate tothe left side 26, so that it is disposed in close relation to the pullassembly 50. A switch assembly 132 is proximate the battery supply 131and connected to the PCB 40. The switch assembly 132 is disposed abovethe pull assembly 50, opposite the battery supply 131, and is useful formaintaining the dispenser 10 in the storage state and later easilymoving it into the use state. The switch assembly 132 includes upperelectrical contacts 133 interrupted from the battery supply 131 by thepull assembly 50 threaded therebetween. The pull assembly 50 isconstructed of a non-conductive material, and so when the pull assembly50 is interposed between the upper electrical contacts and the batterysupply 131, electrical communication between the upper electricalcontacts 133 and the battery supply 131 is prevented and the switchassembly 131 is open. When the pull assembly 50 is removed from theswitch assembly 132, such as would occur when a user grasps and pullsthe pull assembly 50 to energize the dispenser 10 from the storage stateto the use state, the upper electrical contacts 133 and the batterysupply 131 are brought into contact with each other and are coupled inelectrical communication. Coupling the upper electrical contacts 133 tothe battery supply 131 in electrical communication closes the switchassembly 132 and energizes the dispenser 10 by providing power to thePCB 40.

Returning to FIG. 3, but with reference also still to FIG. 4, the tubingset 65 is shown. The tubing set 65 extends between and joins in fluidcommunication the diluent reservoir 12, the drug reservoir 13, and theadministration line 14. The tubing set 65 includes an upper tube 140extending directly between the diluent reservoir 12 and the drugreservoir 13, a down tube 141 extending downwardly from the diluentreservoir to a tee 142, a pump tube 143 extending between the tee 142and the drug reservoir 13 and routed through a pump assembly 150, and anexit tube 144 which extends from the tee 142 to a coupling at the bottom25 of the housing 11 coupled to the administration line 14 outside thehousing 11. The tubing set 65 is sterilized. Each of the tubes 140, 141,143, and 144 are constructed of a material or combination of materialshaving characteristics of flexibility, fluid impermeability, andcompressibility, such as polyvinylchloride, polyurethane, silicone, orthe like. The upper tube 140 is press fit onto the barbed coupling 94 ofthe LDAC 73 and the barbed coupling 125 of the LLAC 111. The diluenttube 141 is press fit onto the barbed coupling 95 of the LDAC 73 and thepump tube 143 is press fit onto the barbed coupling 126 of the LLAC 111.

The down tube 141, the pump tube 142, and the exit tube 144 are a singlepiece, formed monolithically to each other and joined at the tee 142.Within the tee 142 is a check valve that controls the direction of flowwithin the tubing set 65. The pump assembly 150 operates in either a mix(through reconstitution or dilution) state or a dispense state. When thepump assembly 150 is in the mix state, diluent flows out of the diluentreservoir 12 down the diluent tube 141, through the tee 142, through thepump tube 143, and into the drug reservoir 13, before returning to thediluent reservoir 12 for continued mixing and further cycling. Thus,when the pump assembly 150 is operating in the mix state, the checkvalve within the tee 142 allows fluid to move only from the diluent tube141 to the pump tube 143. Then, when the pump assembly 150 is placed inthe dispense state, fluid flows out of the diluent reservoir 12 directlyto the drug reservoir 13 through the upper tube 140, then down the pumptube 143, through the tee 142, and down the exit tube 144 to theadministration line 14. Thus, in the dispense state of the pump assembly150, fluid is prevented from returning to the diluent reservoir 12; thetee 142 allows fluid to move only from the pump tube 143 to the exittube 144.

The pump assembly 150 draws diluent from the diluent reservoir 12 to mixwith and reconstitute or dilute the drug in the drug reservoir 13, toform a liquid medicament. As the terms are used here, diluent will referto both pure diluent and diluent that has begun to be mixed with thedrug, and liquid medicament is diluent that has been fully mixed withthe reconstituted or diluted drug to the appropriate concentration fordispensing to the patient. FIGS. 5, 6, and 7 show the pump assembly 150best. FIG. 5 illustrates the pump assembly 150, the LACA 64, the pullassembly 51, and the pump tube 143 routed through the pump assembly 51,isolated from the housing 11 and the other components in the housing 11.

The pump assembly 150 includes a motor 151 with a small spur gear 152secured on its shaft for rotation. The motor 151 is a DC or step motorpowered by the battery supply 131 and controlled by a MOSFET or otherlogic on the PCB 40. The spur gear 152 is sufficiently long to extendinto a box 153 holding a reduction gear 154 and a main gear 155; thespur gear 152 is meshingly engaged to the reduction gear 154, and thereduction gear 154 in turn is meshingly engaged to the main gear 155.Two rollers 156 are held against the main gear 155, and a cap 157 fitsover the rollers 156 and into the main gear 155 to hold the rollers 156with and against the main gear 155 during rotation thereof. The rollers156 each include axial bores 160 that correspond to through-holes in themain gear 155, and the cap 157 includes two posts 161 that extendthrough the bores 160 and the through-holes to lock into the main gear155, thereby securing the rollers 156 in corresponding rotation with themain gear 155. The cap 157 further includes a square-shaped plug 162that fits into a corresponding socket in the main gear 155. FIGS. 5-7show an embodiment in which there are two rollers 156, but there may bethree or four rollers 156 in other embodiments. The rollers 156 extendtoward the right side 27 of the housing 11 from the main gear 155parallel to the axis of rotation of the main gear 155.

The box 153 includes a left panel 163 and a right panel 164 mated toeach other. Referring briefly to just FIG. 6, the right panel 164includes an arcuate, roughly semi-circular internal wall 165. The pumptube 143 is routed through the pump assembly 150 inside the box 153 andalong an inside face 166 of the internal wall 165. The tube set 143 isdisposed between the internal wall 165 and the rollers 156, and therollers 156 rotate to impinge and compress the pump tube 143 against theinside face 166 of the internal wall 165 to occlude the pump tube 143.When the main gear 155 is rotated so that the two rollers 156 compressthe pump tube 143, diluent or liquid medicament—depending on theoperational state of the dispenser 10—is trapped in the pump tube 143between the two rollers 156 so that a certain volume of diluent orliquid medicament is controllably withheld in the tube set 143 and thenreleased into the rest of the tubing set 65 when the leading rollerstops compressing the pump tube 143. As will be described later, themotor 151 rotates the main gear 155 in both directions, depending on theoperational state of the dispenser 10, so that either of the rollers 156may be leading rollers 156.

Referring to FIGS. 4 and 7 now, the pump tube 143 extends out of thepump assembly 150 to the tee 142, from which the exit tube 144 dependsdown the bottom 25 of the housing 11. Before the tubing set 65 exits thehousing 11, however, it passes a force-sensing resistor 170 mounted tothe PCB 40. A constricting channel 171 is carried over the tubing set 65opposite the force-sensing resistor 170. The constricting channel 171 isa rigid, elongate, semi-cylindrical structure secured to the PCB 40. Theconstricting channel 171 has an inner diameter equal to the outerdiameter of the tubing set 65 and prevents the tubing set 65 fromswelling or expanding radially. The force-sensing resistor 170 isdisposed on the PCB 40 at the constricting channel 171, so that thetubing set 65 is in direct contact with the force-sensing resistor 170when routed through the constricting channel 171. The force-sensingresistor 170 is coupled in electrical communication to logic carried onthe PCB 40. The force-sensing resistor 170 measures a compressive forceacting on it, and with the logic on the PCB 40, determines the extent ofswelling or radial expansion in the tubing set 65, and, correspondingly,a correlated internal pressure of the tubing set 65. In someembodiments, the tubing set 65 has a thin sidewall, allowing for moreprecise measurements of force.

The exit tube 144 bends downward and into a strain-relief coupling 180fitted into the bottom 25 of the housing 11 and to which theadministration line 14 is coupled. The administration line 14 is a long,flexible, tubing terminating in the coupling 15, which is a luer fittingor the like, and is capped to maintain the sterility of theadministration line 14.

A medical professional preparing the dispenser 10 for use with a patientobtains the dispenser 10 in preferably a packaged state. The dispenser10, including the housing 11, the components within the housing 11, andthe administration line 14, are contained within the packaging. Suchpackaging need not necessarily be a sterilized packaging, given that thefluid communication path 62 was previously sterilized before assemblyand will thus be sterile upon the opening of the packaging by themedical professional. The fluid communication path 62, being composed ofthe diluent reservoir 12, the drug reservoir 13, the DACA 63, the LACA64, the tubing set 65, and the administration line 14, is sterilized inseveral separate steps.

In one step, the diluent reservoir 12 is filled with the diluent andthen applied with the UDAC 72. The upper ribbon 53 is already sealed tothe face 85 of the UDAC 72. The entire assembly of the diluent reservoir12, the UDAC 72, and the upper ribbon 53 is then sterilized withconventional sterilization methods. This places the diluent reservoir 12in a long-term, sterilized state. In an embodiment of another step, thedrug reservoir 13 is filled with a liquid drug, which is thenlyophilized (freeze-dried) into a powder according to conventionalmethods. In an alternate embodiment of the other step, the drugreservoir 13 is filled with a powdered drug. In another embodiment ofthe other step, the drug reservoir 13 is filled with a crystalline drug,or the drug reservoir 13 is filled with a liquid drug which is thensubjected to a conventional crystallization process. In yet anotherembodiment of the other step, the drug reservoir 13 is filled with asolution state drug and maintained in that solution state. Regardless ofthe method of filling the drug reservoir 13 with the drug, the ULAC 110,with the upper ribbon 56 already sealed to the face 118, is applied tothe drug reservoir 13 and sealed thereto with an irreversible press-fitengagement; the neck of the drug reservoir 13 is pressed fully into theULAC 110 until the neck makes contact with the base 113, forming a sealwith the ULAC 110. This places the drug reservoir 13 in a long-term,sterilized state. In another step, the tubing set 65 is capped with theLDAC 73 (the down tube 141 is press fit onto the barbed coupling 95 andthe upper tube 140 is press fit onto the barbed coupling 94), the LLAC111 (the pump tube 143 is press fit onto the barbed coupling 126 and theupper tube 140 is press fit onto the barbed coupling 125), and thestrain-relief coupling 180, and the assembly is then Gamma- orETO-sterilized. The lower ribbons 54 and 57 are applied to the LDAC 73and LLAC 111, respectively, before the LDAC 73 and LLAC 11 are coupledto the tubing set 65. The administration line 14 is similarlysterilized.

Each of these components being sterilized and now defining a closedsystem, they are then assembled into the housing 11. The housing 11already includes the pump assembly 150, the PCB 40, and the batterysupply 131 applied therein. There are two methods of assembling thetubing set 65 and administration line 14 to the housing 11, depending onthe construction of the housing 11. When the housing 11 is constructedfrom two or more pieces, and a seam runs along the bottom of thehousing, the tubing set 65 and administration line 14 are coupled toeach other with a strain-relief coupling 160 and sterilized. Theassembly of the tubing set 65, the administration line 14, and thestrain-relief coupling 180 are then placed into a piece of the housing11, and an opposing piece of the housing 11 is applied thereto, with thestrain-relief coupling 180 fit into a hole formed between the two piecesof the housing 11 at the bottom 25 of the housing 11. Alternatively,when the housing 11 is constructed from a single piece of material, andincludes a hole at the bottom 25, the tubing set 65 is placed into thehousing and the strain-relief coupling 180 is fit into the hole at thebottom 25 of the housing 11. The administration line 14 is then coupledto the strain-relief coupling 180 and sterilized.

The drug reservoir 13 is then placed into the housing 11, and the ULAC110 is mated against the LLC 111 so that the upper and lower ribbons 56and 57 are against each other to form the pull assembly 51. The pullassembly 51 is threaded through the slit 55 in the back 23 of thehousing 11. Finally, the diluent reservoir 12 is placed into the housing11 atop the drug reservoir 13, and the UDAC 72 and LDAC 73 are matedagainst each other. The upper and lower ribbons 53 and 54 are againsteach to form the pull assembly 50 which is threaded through the slit 52on the left side 26 of the housing 11. The pull assembly 50 is alsopassed between the battery supply 131 and the switch assembly 132 toprevent electrical contact therebetween. Assembled in this manner, thesterility of the fluid communication path 62 is maintained andprotected. The dispenser 10 is then ready for shipping throughdistribution to medical professionals in this storage state.

When a medical professional receives the dispenser 10, it is initiallyin the storage state and is thus not capable of dispensing liquidmedicament. The medical professional prepares a dispenser 10 for usefirst by selecting the appropriate dispenser 10 containing themedicament needed. For example, if vancomycin must be administered tothe patient, the medical professional obtains a dispenser 10 containinglyophilized vancomycin. It is noted here that the dispenser 10 iseffective at delivering a variety of drug products, including drugswhich are administered at fixed rate, at a variable rate, based on apatient weight, a patient surface area, or on some other basis.

Non-limiting examples of solid state drugs, such as dried, powdered,lyophilized powdered, or crystallized drugs, for use in the dispenser 10include, but are not limited to: Vancomycin, Cefazolin, Cefoxitin,Ceftriaxone, Linezolid, Ampicillin, Solu-cortef®, Pipracil®,Azithromycin, Cefepime, Veftazidime, Cefuroxime, Oxacillin, Meropenem,Cefotaxime, Gentamicin, Tobramycin, Cimetidine, Bexxar®, Emend®,Campath®, Flagyl®, Levaquin®, Unasyn®, Zosyn®, Cefoxitin, Primaxin®,Ampicillin, Clindamycin, Cefepime, Caspofungin, Cefotetan, Meropenem,Tobramycin, Primaxin, Quinupristin and Dalfopristin (Synercid®),Rifampin, Cladribine, Thiotepa, Taliglucerase Alfa (Elelyso®),Velaglucerase Alfa (Vpriv®), IVIG, Hemin, Trastuzumab (Herceptin®,Herclon™), Cyclophosphamide (Lyophilized cytoxan, Endoxan, Cytoxan®,Neosar®, Procytox, Revimmune™, Cycloblastin), Dacarbazine (DTIC-Dome®),Plicamycin (Mithracin™), Trimetrexate, Mitomycin, Sargramostim(Leukine®), Bendamustine, Bortezomib (Velcade®), Gemtuzumab Ozogamicin(Mylotarg®), Fludarabine, Gemcitabine, Carmustine, Dacarbazine,Dexrazoxane, Doxorubicin, Etoposide, Ifosfamide, and Pembrolizumab(Keytruda®) (anti-PD1).

Non-limiting examples of solution state drugs for use in the dispenserinclude, but are not limited to: Tysabri®, Actemra®, Dolasetron,Labetolol, Soliris®, Bleomycin™, Arzerra®, Dobutamine, Bevacizumab(Avastin®), Filgrastim (Neupogen®), Panitumumab (Vectibix®), Dacarbazine(DTIC-Dome®), Docetaxel, Mitoxantrone, Sargramostim (Leukine®),Teniposide (Vumon®), Rituximab (Rituxan®), Cetuximab (Erbitux®),Gemtuzumab Ozogamicin (Mylotarg®), Irinotecan, Oxaliplatin, Paclitaxel,Topotecan, Vinorelbine, Carboplatin, Cisplatin, Dacarbazine,Doxorubicin, Idarubicin, Oxaliplatin, Nivolumab (Opdivo®) (anti-PD1),docetaxel (DOCEFREZ®) (Taxotere®), paclitaxel (TAXOL®), ferumoxytol(Ferheme®), dexmedetomedine (Precedex®), and all taxanes (cabazitaxel,Paclitaxel®, Docetaxel®) (diterpenes produced by the plants of the genusTaxus (yews) featuring a taxadiene core).

Non-limiting examples of other drugs for use in the dispenser 10include, but are not limited to: Pidilizumab (anti-PD-1), ipilimumab(anti-CTLA-4), anti-PD1 (anti-programmed death receptor-1), anti-PD-L1(anti-programmed death receptor-1 Ligand), durvalumab (anti-PD-L1),avelumab (anti-PD-L1), atezolizumab (anti-PD-L1), anti-OX40 (anti-CD134MoAb), anti-4-1BB (anti-CD137 monoclonal antibody) (urelumab), anti-GITR(anti-human glucocorticoid-induced tumor necrosis factor receptor (GITR)agonistic monoclonal antibody (MoAb)), anti-TIM2 (T cell immunoglobulinand mucin domain containing 2 Antibody), anti-LAG3 (monoclonal antibodydirected against the inhibitor receptor lymphocyte activation gene-3(LAG-3™)), anti-TNFRSF25 (mAb that binds to Tumor Necrosis Factor (TNF)receptor superfamily member 25 (TNFRSF25)), anti-ICOS (anti-induciblecostimulator (ICOS), member of the costimulatory molecule family), alllight-activated drugs for tumor ablation, anti-EGFR, anti-TGFbeta, IDOand TDO inhibitors, kynurenine inhibitors and cleavage enzymes allinhibitors of the tryptophan metabolic pathway, anti-phosphatidylserineantibody-drug conjugates containing a tumor-targeting moiety and acytotoxic moiety, bi-specific antibodies or proteins containing targetspresent on tumor cells and T cells, or on tumor cells and B cells, or ontumor cells and other lymphocytes, or on T cells and antigen-presentingcells, anti-VEGF, BTK inhibitors, RAS inhibitors, MET inhibitors, andany combinations of two or more of the above agents.

After selecting the appropriate dispenser 10, the medical professionalremoves the dispenser 10 from its packaging and arranges the dispenser10 for use, such as by hanging from the hole 21 off of a stand proximateto the patient. The cap on the coupling 15 is removed and connected to acatheter already secured to the patient. In this manner, the fluidcommunication path 62 is coupled to the catheter on the patient withminimal opportunity for contamination. The medical professional thenbegins operating the dispenser 10.

The dispenser 10 is shipped in the storage state. In the storage state,the fluid communication path 62 is sterile and connected to the diluentreservoir 12, to the drug reservoir 13, and through the pump assembly150, but is occluded by the upper and lower ribbons 51 and 52 on theDACA 3 and the upper and lower ribbons 56 and 57 on the LACA 64.Further, in the storage state, the dispenser 10 is not energized: nopower is provided to the PCB 40 or the motor 151, and the PCB 40 and themotor 151 are each electrically isolated from the battery supply 131. Tooperate the dispenser 10 in the use state, the medical professional mustfirst both energize the dispenser 10 and remove these occlusions.

Energizing the device is accomplished by pulling and removing the pullassembly 50, which removes the occlusion formed by the upper and lowerribbons 53 and 54 in the DACA 63. As the pull assembly 50 is drawn outof the housing 11, the upper and lower ribbons 53 and 54 are peeled offof the faces 85 and 98, and the gaskets 86 and 99 come into direct andsealing contact with each other, still biased into compression with eachother. With the UDAC 72 and LDAC 73 maintained in coaxial alignment bythe fingers 100 and the gaskets 86 and 99 thus also maintained incoaxial alignment, the major bores 81 and 92 and the minor bores 82 and93 in the UDAC 72 and LDAC 73 are coupled in respective fluidcommunication with each other. At approximately the same time, the pullassembly 51 is pulled and removed from the housing 11, which removes theocclusion formed by the upper and lower ribbons 56 and 57 in the LACA64. As the pull assembly 51 is drawn out of the housing 11, the upperand lower ribbons 56 and 57 are peeled off of the faces 118 and 129, andthe gaskets 120 and 130 come into direct and sealing contact with eachother, still biased into compression with each other. With the ULAC 110and LLAC 111 maintained in coaxial alignment by the fingers 101, and thegaskets 120 and 130 thus also maintained in coaxial alignment, the majorbores 114 and 123 and the minor bores 115 and 124 of the ULAC 110 andLLAC 111 are coupled in respective fluid communication with each other.

Further, with the pull assembly 50 removed from the housing 11, thebattery supply 131 and the switch assembly are coupled in electricalcontact, so that power is supplied to the PCB 40 and the motor 151 fromthe battery supply 131. The dispenser 10 is now arranged in the usestate and ready for operation by the medical professional. There are twotypes of use states of the dispenser 10: a mix state and a dispensestate. The dispenser 10 is programmed to not enter the dispense stateuntil the mix state has been concluded. Thus, the medical professionalmust first place the dispenser 10 into the mix state.

Depending on the drug contained with the dispenser 10, the medicalprofessional will operate the setting and navigation buttons 34-36differently. Each time one of the buttons 34-36 is depressed, thedispenser 10 produces a tactile, haptic, or audible feedback to themedical professional to provide additional confirmation that a buttonhas been pressed. A small, eccentric motor and speaker assembly ismounted in the interior 60 of the housing 11 and coupled to the batterysupply 131 and the PCB 40. In response to one of the buttons 34-36 beingdepressed, the eccentric motor rotates, or the speaker emits a sound,such as a beep. When the medical professional has selected the correctsetting, the medical professional will depress the mix button 41.Depression of the mix button 41 places the dispenser in the mix state,and initiates reconstitution, mixing, or dilution of the drug, dependingon whether the drug is a solid state or solution state drug. Logic onthe PCB 40 initiates operation of the motor 151 to rotate the spur gear152, causing the main gear 155 to rotate in the direction A as indicatedin FIG. 5 and FIG. 6. The pump assembly 150 thus pulls diluent from thediluent reservoir 12, down the diluent tube 141, through the tee 142,through the pump tube 143, and into the drug reservoir 13 beforereturning to the diluent reservoir 12 along the upper tube 140 forcontinued mixing and further cycling. Mix times vary by drug, buttypically range between ten seconds and five minutes. In some cases,mixing requires the medical professional to gently swirl or move thedispenser 10 to agitate the fluid and promote mixing. The main gear 155rotates until the drug is fully reconstituted or diluted, evenlydistributed through the diluent, and the resulting liquid medicament ishomogenous. An alert, such as a blinking light or an auditory beep,indicates to the medical professional that the liquid medicament isready for dispensation to the patient. The display 33 shows the menusand settings through which the medical professional navigates.

To dispense the liquid medicament to the patient, the medicalprofessional depresses the dispense button 42. Depression of thedispense button 42 places the dispenser 10 in the dispense state. ThePCB 40 initiates operation of the motor 151 to rotate the spur gear 152in a direction opposite to the previous direction. This causes the maingear 155 to rotate in the direction B indicated in FIG. 5 and FIG. 6.The pump assembly 150 now pulls liquid medicament out of the diluentreservoir 12 through the upper tube 140, into the drug reservoir 13,down through the pump tube 143 routed through the pump assembly 150,through the tee 142, and down the exit tube 144 to the administrationline 14. The motor 151 rotates at a speed determined by the logic on thePCB 40 based on the parameters selected by the medical professional andshown in the display 33. The rotational speed of the main gear 155 ismonitored by an optical assembly. The optical assembly includes atransmitter emitting an optical signal, such as a light or laser, and areceiver disposed on opposed sides of the main gear 155, such as in theleft and right panels 163 and 164. The main gear 155 is slotted withregular, pie-shaped holes, so that the main gear 155 periodically andregularly blocks and allows the optical signal. When the main gear 155interposed between the transmitter and receiver, the optical signal isblocked and the receiver records nothing. When one of the holes on themain gear 155 is disposed between the transmitter and the receiver,however, the optical signal is received and the receiver records suchreceipt. Hence, the optical assembly records a series of interspersed,sequential receipts of the optical signal, and because the width of theholes is known, logic on the PCB 40 determines the rotational speed ofthe main gear 155 from the number of successful optical receipts and theduration of such receipts. This, in turn, allows the logic on the PCB 40to determine the rate at which diluent is being supplied to the drugreservoir 13 (during the mix state) and the rate at which medicament issupplied to the patient (during the dispense state). Dispensation of theliquid medicament is paused or stopped by depressing the dispense button42 a second, and is then resumed by depressing it again.

A preferred embodiment is fully and clearly described above so as toenable one having skill in the art to understand, make, and use thesame. Those skilled in the art will recognize that modifications may bemade to the described embodiment without departing from the spirit ofthe invention. To the extent that such modifications do not depart fromthe spirit of the invention, they are intended to be included within thescope thereof.

The invention claimed is:
 1. An aseptic connector assembly comprising:an upper aseptic connector in which an upper gasket is received, anopposed lower aseptic connector in which a lower gasket is received, andocclusions acting as barriers to fluid migration between the upper andlower aseptic connectors; the occlusions are removable from between theupper and lower gaskets to change the aseptic connector assembly from astorage state to a use state; in the storage state of the asepticconnector assembly, the upper and lower aseptic connectors are coupledand compressed together, thereby compressing the upper and lower gasketsagainst each other with the occlusions therebetween, and the occlusionsocclude the aseptic connector assembly preventing fluid migrationthrough the aseptic connector assembly; and in the use state of theaseptic connector assembly, the upper and lower aseptic connectors arecoupled and compressed together, thereby compressing the upper and lowergaskets against each other, and the occlusions are removed from theaseptic connector assembly, thereby bringing the upper and lower gasketsinto direct and sealing contact with each other, defining a pathway forfluid migration through the aseptic connector assembly; wherein, as theaseptic connector assembly is moved from the storage state to the usestate, the upper and lower aseptic connectors remain coupled to eachother and are maintained in coaxial alignment with each other.
 2. Theaseptic connector assembly of claim 1, wherein the occlusions compriseupper and lower ribbons over the upper and lower gaskets, respectively.3. The aseptic connector assembly of claim 2, further comprising: a faceof the upper aseptic connector in which the upper gasket is received; aface of the lower aseptic connector in which the lower gasket isreceived; and the upper and lower ribbons are adhered to the respectivefaces of the upper and lower aseptic connectors.
 4. The asepticconnector assembly of claim 2, wherein the upper and lower ribbons areagainst each other between the upper and lower aseptic connectors. 5.The aseptic connector assembly of claim 1, wherein removal of theocclusions is irreversible.
 6. The aseptic connector assembly of claim1, further comprising fingers formed on one of the upper and loweraseptic connectors, the fingers coupling and holding the upper and loweraseptic connectors together in compressive, mating engagement.
 7. Theaseptic connector assembly of claim 1, wherein the occlusions areencased within the aseptic connector assembly.
 8. The aseptic connectorassembly of claim 7, further comprising: a pull assembly coupled to theocclusions, the pull assembly extending outside of the aseptic connectorassembly; and removal of the pull assembly removes the occlusions fromthe aseptic connector assembly.
 9. An aseptic connector assemblycomprising: an upper aseptic connector and a lower aseptic connector,each including: a base, and a stem extending from the base; a boreformed entirely through the base and stem, providing a pathway for fluidmigration through the base and stem; a seat formed in a face of the baseopposite the stem, and a gasket fit into the seat; and an occlusionsealing the bore and acting as a barrier to fluid migration through thebase and stem; wherein the upper and lower aseptic connectors arecoupled to each other.
 10. The aseptic connector assembly of claim 9,wherein each occlusion comprises a ribbon over the bore.
 11. The asepticconnector assembly of claim 10, wherein each ribbon is adhered to theface of the respective aseptic connector.
 12. The aseptic connectorassembly of claim 10, wherein the ribbons of the upper and lower asepticconnectors are against each other between the upper and lower asepticconnectors.
 13. The aseptic connector assembly of claim 9, wherein theocclusions are irreversibly removable.
 14. The aseptic connectorassembly of claim 9, further comprising fingers formed on one of theupper and lower aseptic connectors, the fingers coupling and holding theupper and lower aseptic connectors together in compressive, matingengagement.
 15. The aseptic connector assembly of claim 9, wherein eachof the occlusions is encased within the aseptic connector assembly. 16.The aseptic connector assembly of claim 15, further comprising; a pullassembly coupled to each of the occlusions, the pull assembly extendingoutside of the aseptic connector assembly; and removal of the pullassembly removes each of the occlusions from the aseptic connectorassembly.
 17. The aseptic connector assembly of claim 9, wherein thebore in each of the upper and lower aseptic connectors comprises atleast one bore.
 18. An aseptic connector assembly comprising: an upperaseptic connector and a lower aseptic connector, each including: a base,and a stem extending from the base; a bore formed entirely through thebase and stem, providing a pathway for fluid migration through the baseand stem; and an occlusion sealing the bore and acting as a barrier tofluid migration at the base; a pull assembly coupled to the occlusions;wherein, in a storage state of the aseptic connector assembly, theocclusions are entirely encased within the aseptic connector assemblyand occlude a fluid communication path through the aseptic connectorassembly; and removal of the pull assembly removes the occlusions andopens the fluid communication path through the aseptic connectorassembly, thereby arranging the aseptic connector assembly into a usestate.
 19. The aseptic connector assembly of claim 18, wherein eachocclusion comprises a ribbon over the bore.
 20. The aseptic connectorassembly of claim 19, further comprising, for each of the upper andlower aseptic connectors, a face of the base opposite the stem, whereinthe ribbon is adhered to the face.
 21. The aseptic connector assembly ofclaim 19, wherein the ribbons of the upper and lower aseptic connectorsare against each other between the upper and lower aseptic connectors.22. The aseptic connector assembly of claim 18, wherein removal of theocclusions is irreversible.
 23. The aseptic connector assembly of claim18, further comprising fingers formed on one of the upper and loweraseptic connectors, the fingers coupling and holding the upper and loweraseptic connectors together in compressive, mating engagement.
 24. Theaseptic connector assembly of claim 18, wherein the pull assemblyextends outside of the aseptic connector assembly.
 25. The asepticconnector assembly of claim 18, wherein the bore in each of the upperand lower aseptic connectors comprises at least one bore.